SILONY MEDICAL

Description of Event or Problem

INFORMATION BY INITAL COMPLAINT REPORTER: DURING A SURGERY A CROSS CONNECTOR SHOULD BE IMPLANTED. WHEN THE NURSE OPENED UP THE CARTON PACKAGING OF THE DOUBLE-STERILE BARRIER PACKED IMPLANT, SHE NOTICED THAT BOTH STERILE BARRIERS WERE BROKEN. THE INVOLVED IMPLANT WAS DISCARDED AND SENT BACK TO THE MANUFACTURER. ACCORDING TO SURGEONS INFORMATION THE SURGERY WAS FINISHED WITH A "TEMPORARY INJURY OR IMPAIRMENT THAT DOES NOT REQUIRE FURTHER SURGICAL TREATMENT". INFORMATION BY MANUFACTURER AFTER EVALUATION OF INCIDENT: A DEMO IMPLANT THAT HAD PREVIOUSLY BEEN REWORKED FOR DEMONSTRATION PURPOSES WAS INADVERTENTLY RELEASED AND DISTRIBUTED AS A STERILE PRODUCTION IMPLANT. DURING REWORK, THE OUTER CARTON AND BOTH STERILE BARRIER SYSTEMS HAD BEEN INTENTIONALLY OPENED, RENDERING THE DEVICE NON-STERILE. DUE TO AN INTERNAL INVENTORY HANDLING ERROR, THE DEMO DEVICE WAS INCORRECTLY BOOKED AND RELEASED AS A SERIAL PRODUCTION IMPLANT AND SHIPPED TO A CLINIC IN GERMANY. PRIOR TO IMPLANTATION, OPERATING ROOM PERSONNEL IDENTIFIED THAT BOTH STERILE BARRIERS HAD ALREADY BEEN OPENED. THE DEVICE WAS NOT IMPLANTED, NO PATIENT WAS EXPOSED, AND NO INJURY OCCURRED. A MINOR DELAY IN THE SURGICAL PROCEDURE WAS REPORTED.

Additional Manufacturer Narrative

MANUFACTURER INVESTIGATION CONFIRMED THAT THE DEVICE WAS ORIGINALLY MANUFACTURED AS A STERILE SERIAL IMPLANT (LOT YHH103P) AND WAS SUBSEQUENTLY REWORKED FOR DEMONSTRATION PURPOSES. DURING THE REWORK PROCESS, BOTH STERILE BARRIER SYSTEMS WERE INTENTIONALLY OPENED, RENDERING THE DEVICE NON-STERILE AND UNSUITABLE FOR CLINICAL USE. THE INVESTIGATION DETERMINED THAT AN INTERNAL INVENTORY HANDLING ERROR RESULTED IN THE DEMO DEVICE BEING INCORRECTLY BOOKED AND RELEASED AS A SERIAL PRODUCTION IMPLANT. THE DEVICE WAS SUBSEQUENTLY SHIPPED TO A CUSTOMER FACILITY IN GERMANY. PRIOR TO IMPLANTATION, OPERATING ROOM PERSONNEL IDENTIFIED THAT BOTH STERILE BARRIER SYSTEMS HAD ALREADY BEEN OPENED. THE DEVICE WAS NOT IMPLANTED AND NO PATIENT EXPOSURE OCCURRED. NO INJURY OR ADVERSE HEALTH CONSEQUENCE WAS REPORTED. A MINOR DELAY IN THE SURGICAL PROCEDURE WAS REPORTED. ROOT CAUSE ANALYSIS IDENTIFIED AN INTERNAL PROCESS FAILURE THAT ALLOWED A DEMO DEVICE TO BE INCORRECTLY CLASSIFIED AND DISTRIBUTED AS A SERIAL IMPLANT. A RETROSPECTIVE REVIEW OF ALL SAP REBOOKINGS FROM DEMO TO SERIAL SINCE 2016 IDENTIFIED FOURTEEN SUCH TRANSACTIONS. FIVE WERE VERIFIED AS LEGITIMATE CORRECTIONS OF ERRONEOUS DEMO CLASSIFICATIONS. EIGHT ERRONEOUS REBOOKINGS WERE DETECTED INTERNALLY AND CORRECTED BEFORE CUSTOMER DISTRIBUTION. THE COMPLAINT DEVICE WAS THE ONLY DEVICE DISTRIBUTED TO A CUSTOMER AS A RESULT OF THIS FAILURE MODE. THE AFFECTED DEVICE HAS BEEN PLACED IN QUARANTINE. THE MANUFACTURER CONCLUDED THAT THE EVENT DOES NOT REPRESENT A SERIOUS INJURY EVENT BECAUSE THE DEVICE WAS NOT IMPLANTED, NO PATIENT WAS EXPOSED, AND NO INJURY OCCURRED. HOWEVER, THE EVENT REPRESENTS A REPORTABLE MALFUNCTION BECAUSE RECURRENCE OF THE SAME FAILURE COULD RESULT IN IMPLANTATION OF A NON-STERILE DEVICE AND COULD POTENTIALLY CAUSE INFECTION, REVISION SURGERY, PROLONGED HOSPITALIZATION, OR OTHER SERIOUS INJURY. NO CORRECTION, REMOVAL, RECALL, OR FIELD ACTION WAS INITIATED BECAUSE THE INVESTIGATION CONFIRMED THAT NO ADDITIONAL AFFECTED DEVICES HAD BEEN DISTRIBUTED. THE INVESTIGATION HAS BEEN COMPLETED AND NO FURTHER INFORMATION IS EXPECTED.